Psychological Preparation for Colorectal Surgery: Impact of Video Education

Colorectal Surgery Clinical Trial

Official title:

Psychological Preparation for Colorectal Surgery: Impact of Video Education. A Randomised Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01547572
• Other study ID #: IhediohaU
• Status: Completed
• Phase: N/A
• First received: February 27, 2012
• Last updated: March 7, 2012
• Start date: September 2010
• Est. completion date: November 2011

Study information

• Verified date: March 2012
• Source: Ihedioha, Ugo, M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: England : Research and Developement Office
• Study type: Interventional

Clinical Trial Summary

Since the introduction and favourable early results of enhanced recovery programmes more than a decade ago, such programmes have become increasingly popular following major surgery. Many elements of these programmes are based on solid evidence and derived from published trials. These programmes optimize different factors to reduce the stress of surgery with the aim of improving patient outcome and speed up recovery after surgery. Key factors prior to surgery are conditioning of expectations and optimizing associated disease. Strategies during the operation include use of short-acting anaesthetic (sleeping) agents, maintenance of normal temperatures and minimal access surgery (keyhole surgery).

Care after surgery is optimized with appropriate analgesia (pain killers), early mobilisation (walking) and early feeding. This combined approach reduces hospital stay to 2-4 days. There is also evidence that the improvements resulting from the implementation of an enhanced recovery programme do not cause significant deterioration in quality of life or transfer costs to another component of health care.

The relative contribution of each of the single elements in the enhanced recovery programme remains uncertain. Good patient information gives confidence and improves overall outcome. No studies have examined the impact of video education on recovery.

The aim of this study is to explore the use of video information provision for patients participating in an enhanced recovery programme.

Description:

TRIAL DESIGN:

A randomised controlled trial of the impact of video education in preparing patients for surgery within an enhanced recovery programme. Patients will be recruited from Leicester General Hospital and will include everyone undergoing colorectal(bowel) surgery. A standard protocol (treatment regime) is in place for all such patients. The primary end-point (main aim) will be length of hospital stay. Secondary end-points (other factors to be considered) will be patient satisfaction scores (using SF-36 outcomes in patients) and will allow the investigation of the potential implications of incorporating video education of enhanced recovery programmes into routine clinical practice.

METHODS:

All surgeons treating the patients in this trial will have a specialist interest in colorectal (bowel) surgery. All patients undergoing planned bowel surgery for benign (non-cancerous) and malignant (cancerous) disease will be eligible. Patients who cannot speak or understand english will have interpreters. Ethics approval will be sought and informed (signed) consent both for the surgery and the trial will be obtained. The study group will get a video and leaflet and the control group will receive a leaflet only. Randomisation (Division into groups) will be done using a table of random numbers to assign each study participant to a group. The consultants and registrars in charge of taking care of patients after their surgery will not be aware of which group patients belong to and a standard discharge criteria will be used (Patients for discharge should have normal observations and normal bloods results, free from lines in the hands and tubes in the waterworks, be fully mobile (walking), able to get in and out of bed unaided and dress independently. Hospital stay will be recorded in days from the time the patient is admitted to hospital. Social reasons for non-discharge such as delay in setting up home help etc will be recorded for both groups of patients.

The time to passage of flatus (wind from the back passage) and bowel motion (stool) will be recorded for each patient. Episodes of nausea and vomiting (sickness) will also be recorded as will any complication up to 30 days after surgery.

All patients will complete a questionnaire (SF-36) prior to surgery and at 3 months after surgery to assess satisfaction and return to normal activities such as leisure activities and work in the home etc.

DETAILS OF THE ENHANCED RECOVERY PROGRAMME:

Preoperative preparation (Prior to surgery) All patients will be allowed free fluids (liquids) and high calorie (energy) drinks for up to 2 hours before operation. Patients undergoing right hemicolectomy (right sided bowel surgery) will not receive bowel preparation (bowel cleansing) while those having left sided surgery will receive phosphate enema on the morning of surgery. All patients will receive antibiotic and DVT (blood clot) prophylaxis.

All patients will have baseline blood tests.

Anaesthesia (During surgery)

A standardised anaesthetic (sleeping) protocol (treatment regime) will be used for all patients. Normal temperature will be maintained throughout surgery and all operations will be carried out through the smallest incision (cut) necessary to complete the procedure. No nasogastric tubes (stomach tubes) will be used.

Postoperative pain and analgesia (Pain relief after surgery) Analgesia(Pain relief) will be provided in both groups for 48 hours via PCA (patient controlled pain relief), epidural (pain relief via injection at the back) or TAPP block (pain relief via injection on the belly).

Paracetamol will be administered concurrently with NSAIDS (non steroidal drugs) and tramadol for breakthrough pain once morphine is discontinued. Visual analogue (facial expression) pain scores at rest and movement will be measured daily until discharge. All analgesia (pain relieving drugs) used after surgery will be recorded including any discharge medication.

Diet and Fluids:

Oral fluids will be pushed immediately postoperatively (after surgery) in both groups. In addition, protein drinks and normal food will be encouraged in both groups from day 1. All lines in the arm will be removed by day 2 unless there is a clinical reason to maintain them. Both groups will have daily blood tests.

All patients will have chest physiotherapy (exercises) and will be encouraged to mobilise (walk) on day one with the help of a nurse or physiotherapist.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients undergoing planned bowel surgery for benign (non-cancerous) and malignant (cancerous) disease will be eligible

Exclusion Criteria:

• Patients who are unfit for surgery or undergoing emergency surgery will be excluded.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Colorectal Surgery
• Use of Video Education

Intervention

Procedure:
• The study group will get a video and leaflet on enhanced recovery
The study group will get a video and leaflet
• The control group will receive a leaflet only
The control group will receive a leaflet only

Locations

Country	Name	City	State
United Kingdom	Leicester General Hospital	Leicester	Leicestershire

Sponsors (1)

Lead Sponsor	Collaborator
Ihedioha, Ugo, M.D.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary end-point ( main aim ) will be length of hospital stay.	Hospital stay will be recorded in days from the time the patient is admitted to; hospital.	Participants will be assessed for the duration of their hospital stay which is an average of 7 days.	No
Secondary	Secondary end-points will be patient satisfaction scores	Secondary end-points ( other factors to be considered ) will; be patient satisfaction scores ( using SF-36 outcomes in patients )	Measured 3 months after discharge	No